The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega 2000 Soft Patient Return Electrode Pad.
| Device ID | K021077 |
| 510k Number | K021077 |
| Device Name: | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda K Magneson |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-04-03 |
| Decision Date | 2002-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559101841 | K021077 | 000 |
| 10614559101797 | K021077 | 000 |